‘Not enough vaccines’: US faces monkeypox ‘vaccine cliff’


This week, federal officials touted the arrival of hundreds of thousands of additional doses of monkeypox vaccine, announcing it was an important step in the nation’s fight against the outbreak. What they left out: The United States is entering a critical three-month period where cases could continue to mount, but no more vaccines are expected to arrive until October at the earliest.

Even with the latest shipments, there are only enough vials of the two-dose Jynneos vaccine to cover around a third of the estimated 1.6 million gay and bisexual men authorities consider most at risk and who are encouraged to be vaccinated.

And with cases in the United States doubling roughly every week, some health experts are warning that a lack of vaccine doses could threaten the country’s ability to contain the expanding epidemic and prevent the virus from taking hold. permanently — a concern that some federal officials privately concede.

“When you look mathematically at what the requirements are … we’re up against a tough sled here,” said J. Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies, on a podcast Friday, adding that 3.2 million doses would be needed to fully cover the at-risk population of HIV-positive men and others targeted to receive vaccines by the Centers for Disease Control and Prevention.

“We’re not going to have, until the end of the year, 2 million doses,” Morrison said.

The lack of Jynneos, the only vaccine approved by the Food and Drug Administration to protect against monkeypox, has health officials at all levels of government scrambling for strategies. Those in hard-hit communities like New York and DC have opted to distribute only one dose for now, against the advice of regulators, while pushing federal authorities for larger allocations. Some experts are also advocating that people be encouraged to take a less desirable vaccine, ACAM2000, which has been approved for the related virus smallpox but not monkeypox.

“There are not enough vaccines” to pursue a strategy of relying solely on Jynneos, said a federal official working on the monkeypox response, who spoke on condition of anonymity because they were not allowed to comment, warning of a possible “vaccine cliff” in the coming weeks.

Nearly 5,200 people in the United States, mostly gay and bisexual men, have been diagnosed with monkeypox, which can spreads through skin-to-skin contact and causes fever, swollen glands, severe pain and sores. Most experts estimate that hundreds or thousands of cases likely remain undetected.

“We expect cases to continue to increase in the coming days to weeks as testing becomes more widely available,” a CDC spokesperson said Friday.

Although the virus has not yet been linked to a single confirmed death in the United States, public health officials continue to fear that it will become difficult to eradicate, especially if it affects rodents and other small mammals, which helped drive transmission in Central and West Africa.

US officials said they have now obtained 1.1 million doses of the Jynneos vaccine, including 786,000 doses finally authorized by regulators after being delayed in Denmark for more than a month, and which will be “in the hands of people who need it over the next few weeks,” Health and Human Services Secretary Xavier Becerra said Thursday. Federal regulators reiterated on Friday that the vaccine should be given to most people as a two-dose schedule, meaning U.S. officials have enough vaccine to cover about 550,000 people.

But the total population that federal authorities used to calculate vaccine allocations — which includes people who have been exposed to someone with monkeypox, as well as men who have had multiple sexual partners in the past two weeks in areas of known monkeypox spread – is at least 1.6 million individuals and possibly more, according to the CDC.

Demand is also being driven by people seeking vaccinations who may not fit into these categories but are concerned about potential exposures.

“Overall, there are not enough vaccine doses to meet demand at this time and most jurisdictions are maximizing or exceeding their allocation and in some cases are still unable to meet demand” , concluded the Kaiser Family Foundation, a nonpartisan health care think tank. in a analysis Friday.

If the epidemic spreads to other populations in the coming weeks and millions more Americans are encouraged to get vaccinated, this deficit will be even more pronounced. The first two cases were confirmed in children last week and in a pregnant woman this week. Past outbreaks abroad have spread to children, women and other vulnerable groups.

“If we drift into mass vaccination, that’s going to require huge volumes” of doses, CSIS’s Morrison said.

Experts have struggled to accurately predict the course of the monkeypox outbreak, warning that limited testing has complicated efforts to get a true picture of the spread of the virus. Cases have doubled about every 7.6 days in the United States, said Trevor Bedford, a computational biologist at the Fred Hutchinson Cancer Center.

Seeking to curb local outbreaks, many state and local health officials have demanded as many doses of the Jynneos vaccine as possible, with hardest-hit states like California and New York repeatedly asking the federal government for more doses. than officials say available.

Biden administration officials said they were working to secure more doses, noting they had also acquired raw materials for 11 million potential doses of Jynneos.

“We don’t know what’s next and we need to be prepared for the spread across the population,” Dawn O’Connell, the assistant secretary who oversees the Administration for Strategic Preparedness and Response, said Thursday. But officials said it could take months to find a manufacturing partner to turn those raw materials into vaccine doses.

In addition to vaccinations, the administration touts a multi-pronged strategy, including making testing and treatment accessible and educating high-risk communities on how to protect themselves, which officials say can help contain the epidemic.

“We will continue to look for ways to quickly get more vaccines to populations across the country — but that’s only part of our strategy,” White House spokesman Chris Meagher said in a statement. communicated.

In the meantime, public health officials in New York and DC said they will focus on delivering as many first doses of Jynneos as possible and forgo a second dose for now, hoping to stretch the limited vaccine supply as much as possible.

“DC Health has decided that the most urgent priority is to provide the first doses of the vaccine to high-risk residents,” the city’s health department said in a statement. statement this week. “This is hugely important because getting more people vaccinated with their first vaccine will help us contain the virus.”

Federal officials reiterated Friday that a two-dose strategy is needed for sufficient protection.

“While the FDA understands the desire to release as many doses as possible, the agency advises against deviating from product labeling,” a spokesperson said.

Amanda Jezek, senior vice president of public policy and government relations at the Infectious Diseases Society of America, said local public health clinics are also working to target “underserved individuals” because many appointments you previous for vaccines were “rapped” by disproportionately well off people.

Some experts called US officials instead encouraging Americans to get vaccinated with ACAM2000, which has been approved for smallpox, a related virus, and which the United States had previously stockpiled in case of a potential outbreak. This vaccine relies on injecting people with a live virus, if weakened, which carries additional risks. It is also given in a series of rapid injections which can draw blood and lead to scarring. The vaccine is available when needed, although public health officials are reluctant to rely on it.

“No one is mad about it. You don’t have to be crazy about it. But you should give people a choice,” said Ezekiel Emanuel, a bioethicist who has advised the Biden administration on the coronavirus and attended a White House briefing this week on monkeypox.

Emanuel blamed health officials for not ordering more doses of Jynneos earlier in the outbreak, especially as other countries moved to buy doses. “I don’t know who was negotiating these deals,” he said. “It’s a serious problem.”

The next shipment of 500,000 Jynneos doses from Bavarian Nordic, the Danish manufacturer, are not expected until the end of October in a context of strong global demand, said two administration officials who spoke on condition of anonymity because they were not authorized to speak in public.

“The additional 500,000 doses ordered by the United States in June are expected to be delivered this year,” a Nordic Bavarian spokesperson wrote in an email, declining to answer specific questions about the timeline or commitments from the company. business to other countries.

Sarah Lovenheim, an HHS spokeswoman, said officials accelerated the doses announced this week and are also working to expedite future shipments.

“We will take every opportunity to expedite the path to get more doses ahead of schedule, whenever possible,” Lovenheim said.

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said he was open to the idea of ​​”dose sharing” as a temporary solution, suggesting people could get a dose of Jynneos and a dose of ACAM2000.

“We don’t have a lot of window to fix this,” Hotez said. “Once it enters the rodent population, it becomes a staple here, as it has been in Central and West Africa.”

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